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Neeraj Agarwal: Welcome to this episode of UroToday. I’m Dr. Neeraj Agarwal, Professor of Medicine and Director of the Genitourinary Oncology program at the Huntsman Cancer Institute. And it’s such a pleasure to have two of my close colleagues who presented cutting-edge data at the ASCO GU 2025 symposium—their work, groundbreaking work, from the real-world data sets.

So, first of all, I’d like to introduce you to Dr. Yeonjung Jo, who is a PhD scientist, and her expertise is statistics or biostatistics, and Dr. Umang Swami, medical oncologist and a faculty in the oncology division at the Huntsman Cancer Institute. So welcome to both of you.

So let’s talk about your abstract, talking about time to administration of lutetium-177, or let’s call it PLUVICTO, versus cabazitaxel once you prescribe the drugs to the patient. So there’s a different—significant difference in the time of actual receipt of this drug. So Yeonjung, maybe you can please present your abstract first, and then we can talk about the findings.

Yeonjung Jo: Thanks for introduction, Dr. Agarwal. And I’d like to also thank UroToday for this opportunity. It is my pleasure to present our work on the “Time from Medication Order to the Administration of Cabazitaxel versus Lutetium in Patients with Metastatic Castration-Resistant Prostate Cancer.”

As Dr. Agarwal introduced, my name is Yeonjung Jo, and I’m a research associate at Huntsman Cancer Institute, University of Utah. Today, I’ll share our findings from a retrospective study using the Flatiron Health database.

Here’s a brief introduction and motivation for our study. Cabazitaxel and lutetium are valid treatment options for patients with mCRPC with disease progression on docetaxel and on ARPI. And they have shown overall survival benefit in their respective landmark phase III clinical trials.

In the randomized phase II TheraP trial, a higher PSA response and fewer grade 3 or 4 adverse events were encountered with lutetium. However, in a real-world setting, administering lutetium requires extensive coordination across multiple specialties and resources, which could delay its administration.

So we sought to compare the time from medication order to administering the first dose of cabazitaxel versus lutetium in a large US-based nationwide database. For this study, we used the Flatiron Health database, which is a US-based longitudinal database comprising de-identified patient-level, structured and unstructured data curated via technology-enabled abstraction and originating from approximately 280 cancer clinics.

In this study, we included the first order of single-agent cabazitaxel or lutetium with recorded dates for their order and administration. The analysis includes 2,329 first-time orders of single-agent cabazitaxel or lutetium, and those included in the study were diagnosed with metastatic disease from January 2013 to January 2024.

The primary outcome was the days from order to administration, and we used the Wilcoxon rank-sum test to compare median days. We also looked at the median days by practice type and insurance status.

Of those 2,329 first medication orders, 2,045 were for cabazitaxel, and 284 were for lutetium. At the time of their first orders, patients were significantly older, more likely to be treated at an academic center, and covered by commercial health plans for lutetium compared to cabazitaxel, and these differences were statistically significant. There was no statistically significant difference observed by race and ethnicity.

So here’s the main result. The box plot on the right describes the distribution of the days from order to administration very nicely. The thick line inside the box is the median, and the line above the thick line is the third quartile, and the line below is the first quartile.

As we hypothesized, the median days from order to administration was significantly longer for lutetium, with a median of 22 days and an interquartile range of 12 to 43 days, as compared to cabazitaxel, which had a median of seven days with an interquartile range of three to 14 days. This difference was statistically significant, with a p-value less than 0.001.

We also looked at days from medication order to administration by practice type, which is shown in Figure A on the left panel, and insurance status, which is shown in Figure B on the right panel. The blue box represents cabazitaxel, and the orange box represents lutetium. As you can see in these figures, regardless of the practice type or insurance status, it takes longer for lutetium to be administered after orders, compared to cabazitaxel.

Let’s take a look at Figure A first. In academic settings, the median days for cabazitaxel was zero days, while it was six days for lutetium. In community settings, the median days for cabazitaxel was eight days, while it was 31 days for lutetium.

Moving to Figure B, there were a few statistically significant differences in the outcome observed across insurance settings. In commercial health plans, the median days for cabazitaxel was seven days, while it was 22 days for lutetium. In Medicare or other government programs, the median days for cabazitaxel was seven days, while it was 25 days for lutetium.

For your information, we included this table. The table shows the median, interquartile range, mean, standard deviation, and range of our outcome—days from medication order to administration—by practice type and insurance status. To summarize this table, there were statistically significant differences in the outcome between cabazitaxel and lutetium within academic centers, community centers, commercial health plans, Medicare or other government programs, and unknown insurance status.

Overall, this study highlights a significantly longer time from order to administration for lutetium compared to cabazitaxel. The delay is observed across both academic and community practices, as well as various insurance groups. Potential reasons include regulatory requirements for handling radiopharmaceuticals, infrastructure and logistical barriers, and insurance approval processes.

Our findings suggest a need for improved policies and coordination to enhance access to lutetium. Thank you for listening, and thank you, Dr. Agarwal, Dr. Swami, and the rest of the GU group at the Huntsman Cancer Institute.

Neeraj Agarwal: Congratulations, Yeonjung. Really striking findings. So to summarize for our viewers, both lutetium-177-PSMA-617—I will call it PLUVICTO moving forward—and cabazitaxel are approved drugs associated with improved overall survival for our patients with metastatic castration-resistant prostate cancer.

And there is a significant difference as far as time of prescription to time of administration is concerned between cabazitaxel and lutetium.

What I gathered from your presentation was another striking finding—that the problem was consistently present across the insurance types. And it was present in both academic and community hospitals, although if you look at numerical differences in the time, it was a little shorter—I would say quite shorter—in the academic cancer centers to give lutetium—six days from the time of prescription—to, I would say, almost three weeks in the community hospitals, as far as lutetium delivery is concerned. So what are the implications of these findings, Umang, what we learned from this research and these findings?

Umang Swami: Thanks, Neeraj, for this opportunity to present our study. So when we look at our study, we find out that the administration time to PLUVICTO is three times what it is for cabazitaxel. It is to be noted that these findings count the time from the day these orders are placed.

What we have not captured here is that PLUVICTO is usually ordered after a positive PSMA scan, which itself takes a few weeks because it needs insurance authorization and approval before the actual scan can be done. So the actual time to administration of PLUVICTO may be much longer, going beyond five weeks, six weeks, in real world.

And these findings are very important because, as we have seen in multiple other studies—some of which we have presented in the past—that we lose almost one third of the patients with each subsequent line of therapy.

And if there is a delay of around five, six weeks for administration of a medication, then these patients who have already received an androgen receptor pathway inhibitor and a taxane have very aggressive disease, and most likely they may not be able to wait for six weeks or so. And by that time the drug is approved, they may have a poor performance status or may be unfit to receive these therapies for various other reasons.

And therefore, we need some sort of systemic policy change, better coordination, both from the institutional level—where nuclear medicine and medical oncologists and other stakeholders can expedite this process—and to help the timely availability of these therapies for our patients, as well as with regards to insurance and other authorizations, so that these therapies can be administered in a timely fashion.

Neeraj Agarwal: Good points. First of all, you published a study along with Dr. Dan George, Dr. Freedland, and multiple investigators across the country, and multiple investigators have published that we lose a substantial number of patients after each line of therapies, and likely because patients lose their performance status because of aggressiveness of their disease, and they’re not fit enough to receive any subsequent therapy.

And another interesting point you made was that we are not even counting the time to get the PSMA PET scan, which takes its own preauthorization, own scheduling. And that could be further adding to the delays in actual receipt of lutetium therapy, because it’s not only exactly the order. It’s actually—when you talk to the patient about lutetium is when they are already progressing.

So it’s very concerning that this process could be taking weeks to months, because I can recall some of my patients where it took more than a month to even schedule a PSMA PET scan. So those are very valid points.

So Yeonjung, tell me, what do you see further value of this data set, specifically the Flatiron real-world data set, moving forward? And I’ll come back to lutetium and cabazitaxel in a moment. But you are doing so much research, along with Dr. Swami in this field. What else can we learn from this database?

Yeonjung Jo: So Flatiron collects a lot of data, like line of therapy, unstructured, structured data, and it’s real-world data. And in our research, we cannot conduct clinical trials every time that we want an answer for something. But by utilizing this real-world data, we can draw conclusions. And we can research things with a low cost and more effectively, such as which treatment is working better with some patients or answering questions like this—how long does it take in a real-world setting for patients to receive some kind of drug after it’s ordered?

There are a lot of many—many questions that we can explore without actually conducting a clinical trial. And these days, I’m very interested in more advanced statistical methods to harness this data set, especially like per-protocol analysis.

Neeraj Agarwal: Yeonjung, what you said was really striking. We cannot do clinical trials for every single question out there. So these kinds of databases, especially the Flatiron database, which is patient-level data directly extracted from the electronic medical record from all these institutions—which comprise both academic and community hospitals—can be a very valuable tool to inform the practice, inform the design of future clinical trials by informing overall survival and PFS estimates at each line of therapy, and also can inform about side effects. That’s great. I agree with you, and thank you for sharing that perspective.

So Umang, coming back to you. I think we saw the result from another group of investigators in Germany, from GU ASCO, that lutetium may be better than cabazitaxel as far as efficacy is concerned in the real world. And I know you are working in this field, along with Yeonjung and the team. And you’ll be presenting more data in the upcoming meetings.

But for now, if you are counseling the patients regarding lutetium versus cabazitaxel—because both are choices out there after disease progression on ARPI and docetaxel—how does this data affect your counseling? What will you be telling the patients and your nurses, your team members?

Umang Swami: Thanks, Neeraj. This is a very excellent point with regards to counseling of the patients—and I would urge my fellow oncologists also to keep these reasons for delay in mind before ordering or planning therapies.

So in my practice, I plan to do PSMA scans much earlier so that we can have timely approval of these therapies and we do not lose precious time while waiting for approval, either for the PSMA scan or PLUVICTO or with coordination with my other colleagues in nuclear medicine, and even with patients. So when we present, we explain—

Neeraj Agarwal: But you do have a nuclear medicine—or radiopharmaceutical-based—tumor board, where these patients are assessed on a regular basis for their eligibility and continuation of treatment for radiopharmaceuticals.

Umang Swami: Yes, so we have this excellent support, which might not be available at all institutions. And when counseling these patients, if we can let them know what may be the potential delays and how we can sequence these treatments while we are planning for the next treatment, it may actually help in delivery of these agents in a timely fashion and in a sequential manner.

Neeraj Agarwal: Great points. So when I’m counseling the patient, what I gathered is—I will tell the patient about differences in the actual time it takes to deliver these two drugs. In the academic setting, I was struck by the zero-day interval, basically for cabazitaxel. So you order cabazitaxel, and patients can get cabazitaxel right when they are in the clinic. They can be scheduled to receive cabazitaxel in the respective infusion rooms on the same day, which is a big deal for patients who are traveling for hours to come to the cancer hospital, or who are needing rides from their near and dear ones to come to the cancer center.

So I think this is a very pertinent point from the counseling perspective. And of course, there are no head-to-head comparisons of these two drugs, so we cannot really talk about—in a large trial. TheraP trial was a good trial, which showed lutetium may have an edge, but the trial was not really powered to look for overall survival.

But I think if I have a patient sitting in my clinic who has really progressive disease and I really don’t want to wait, I may lean towards cabazitaxel while I continue to work on preauthorization of lutetium-177 therapy. Would you agree with that?

Umang Swami: Exactly, Neeraj. So this has been my approach lately, after I looked at these data and from my earlier personal experience, that we cannot rely or wait for the next therapy to be available where the therapy administration time may sometimes be unpredictable due to issues such as approval for insurance or PLUVICTO or scheduling the PSMA scans.

So it’s very pertinent that we administer the next available therapy, which I think may be cabazitaxel in this setting, while we continue to work on getting PLUVICTO authorized.

Neeraj Agarwal: Another strategy I heard from you to expedite the delivery or administration of lutetium therapy in our patients is to obtain the PSMA PET scan early on. When the PSA may be rising, when you are even thinking about possibly offering lutetium therapy to the patients, get the PSMA PET scan so that that doesn’t add additional delays to the insurance preauthorization and administration of lutetium therapy. Would you agree with that?

Umang Swami: Yes. And when we see that the patient might be progressing, we should get the PSMA scan so that it doesn’t cause unnecessary delay in the later setting, so I fully endorse this.

Neeraj Agarwal: Thank you very much. So Yeonjung, again, congratulations. Any final message for our viewers today before we conclude the session?

Yeonjung Jo: Yeah, thank you. I think harnessing this kind of real-world data is really important because, as I mentioned before, we cannot conduct a clinical trial every time that we have a question.

And also, this particular question that we answered in this presentation cannot be answered by conducting a clinical trial, because when you conduct a clinical trial, they will expedite the process, and they will administer the lutetium much, much faster, so we won’t be able to see this much delay in order to administration. So yeah, big shout out to Flatiron. Thanks for providing the data. And we always value our collaboration. Yeah. Thank you.

Neeraj Agarwal: Thank you. Thank you to both Dr. Jo and Dr. Swami for being with us today.

Umang Swami: Thanks, Dr. Agarwal and UroToday, for giving us the opportunity.

Yeonjung Jo: Thank you so much, Dr. Agarwal and UroToday.